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Gilead's Vitekta gains European Commission approval

Gilead's Vitekta gains European Commission approval

18-11-2013

The European Commission has granted marketing authorization for US biotech firm Gilead Sciences’ Vitekta…

Anti-viralsBiotechnologyelvitegravirEuropeGilead SciencesRegulationVitekta

2013 FDA approval rates suggest record year for post-launch success

14-11-2013

A focus on hard to treat or specialist diseases is set to result in record post-launch sales for new…

Biogen IdecFinancialGilead SciencesNorth AmericaPharmaceuticalRegulationsofosbuvirTecfidera

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

Unanimous yes vote from FDA advisory panel for Gilead’s sofosbuvir in hep C

27-10-2013

Following swiftly on a similar decision for Janssen’s hepatitis C drug simeprevir, the US Food and…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaRegulationsofosbuvir

EMA advises on compassionate use of sofosbuvir for hepatitis C

EMA advises on compassionate use of sofosbuvir for hepatitis C

25-10-2013

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an…

Anti-viralsEuropeGilead SciencesPharmaceuticalRegulationsofosbuvir

Janssen-Cilag files European approval of combination medicine for HIV-1

16-10-2013

US health care giant Johnson & Johnson subsidiary Janssen-Cilag International NV has submitted a Marketing…

Anti-viralsBiotechnologycobicistatDarunavirEuropeGilead SciencesJanssen-CilagJohnson & JohnsonPharmaceuticalRegulation

Gilead’s HIV drug booster Tybost gets EU marketing authorization

Gilead’s HIV drug booster Tybost gets EU marketing authorization

27-09-2013

US biotech major Gilead Sciences has received marketing authorization from the European Commission for…

Anti-viralsBiotechnologyEuropeGilead SciencesNorth AmericaRegulationTybost

Stribild in HIV shows lesser benefit for treatment-naive patients, says IQWiG

Stribild in HIV shows lesser benefit for treatment-naive patients, says IQWiG

20-09-2013

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products…

Anti-viralsBiotechnologyEuropeGilead SciencesPricingRegulationStribild

Gilead files for US approval of iNHL drug candidate

12-09-2013

US biotech major Gilead Sciences (Nasdaq: GILD), best known for its prowess in antivirals (HIV and hepatitis…

BiotechnologyGilead SciencesidelalisibNorth AmericaOncologyRegulation

AHF claims victory over FDA in HIV prevention drug case

08-08-2013

The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety…

Anti-viralsBiotechnologyGilead SciencesLegalNorth AmericaPharmaceuticalRegulationTruvada

EU approval for Gilead's Stribild for HIV-1 infection

29-05-2013

US biotech major Gilead Sciences (Nasdaq: GILD) says that the European Commission has granted marketing…

Anti-viralsBiotechnologyEuropeGilead SciencesRegulationStribild

US FDA delays approval of Gilead's elvitegravir and cobicistat for HIV

30-04-2013

US antiviral drug specialists Gilead Sciences (Nasdaq: GILD) says it has received Complete Response Letters…

Anti-viralsBiotechnologycobicistatelvitegravirGilead SciencesNorth AmericaRegulation

AHF demands FDA reversal on use of Gilead's HIV prevention pill for women

06-03-2013

Citing another failed clinical trial in women of the use of Gilead Sciences' (Nasdaq: GILD) AIDS drug…

Anti-viralsBiotechnologyGilead SciencesNorth AmericaPharmaceuticalRegulationResearchTruvada

UK's NICE issues draft guideline for diagnosis and management of hepatitis B

17-01-2013

UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is currently developing…

Anti-viralsBaracludeBiotechnologyBristol-Myers SquibbEuropeGilead SciencesNovartisPharmaceuticalPreveonPricingRegulationSebivoViread

Japan Tobacco files for Japanese approval of elvitegravir

11-12-2012

Japan Tobacco (TSE:2914) has filed a New Drug Application for marketing approval of a novel anti-HIV…

Anti-viralsAsia-PacificBiotechnologyelvitegravirGilead SciencesJapan TobaccoPharmaceuticalRegulationTorii Pharma

New Zealand to fund Gilead's Atripla and Truvada

27-11-2012

New Zealand's Pharmaceutical Management Agency PHARMAC says that, effective December 1, it will fund…

Anti-viralsAsia-PacificAtriplaBiotechnologyFinancialGilead SciencesPharmaceuticalRegulationTruvada

Gilead HIV drugs Atripla and Truvada to be listed in New Zealand

13-11-2012

Following a consultation, New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval…

Anti-viralsAsia-PacificAtriplaBiotechnologyGilead SciencesPharmaceuticalPricingRegulationTruvada

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